Regulatory Integration Lead

1 month ago

Søborg, Denmark Novo Nordisk AS Full time

Do you want to be a part of enabling and supporting the growing product portfolio and life cycle management activities in Novo Nordisk? Would you like to be part of shaping how we in Regulatory Affairs drive data integrations/migrations using digital tools/automation?

If you are ready to take on the challenge, we encourage you to apply for this exiting position as Regulatory Integration Lead.

The position
As Regulatory Integration Lead, you will drive activities that enable us to manage regulatory activities across the product portfolio, with a primary focus on securing a smooth and effective integration of acquisitions into our regulatory IT platform Vault RIM.

Your main responsibilities include:

Leading the migration of regulatory documents into Vault RIM in connection with acquisitions, ensuring a smooth transition and compliance with regulatory requirements Collaborating with cross-functional teams to develop and implement integration plans, ensuring alignment with business objectives and timelines Monitoring and reporting on the progress of integration activities, identifying and mitigating risks as necessary Provide guidance and support to project teams, ensuring adherence to regulatory standards and best practices Leveraging digital solutions and AI to secure process scalability, robustness and compliance. 

Qualifications
The ideal candidate has:

A M.Sc. in a relevant field, such as science, pharmacy, or equivalent Minimum 5 years of experience from the pharmaceutical industry, preferably within Regulatory Affairs  Experience working with Vault RIM or other regulatory IT platforms is required Project Management background and experience is an advantage Experience with agile Project Management and Scaled Agile Framework (SAFe) is an advantage High proficiency in English.

As a person you are curious to learn, well-organised and a proactive problem solver. You enjoy working in a diverse team and be part of a global project-centric organisation and are a strong collaborator. You thrive in a dynamic environment and have a can-do attitude as well as a healthy sense of humour. Working with matrix teams, you focus on jointly moving projects, work independently and bring an innovative mindset seeking novel solutions to the challenges we face.

About the department
You will have the unique opportunity to be part of a strategically crucial business transformation across multiple processes and geographies and take active part in shaping the way Regulatory Affairs will work in the future. You will join the RA Submission Systems department that plays a key role to support and enable this transformation. Global Regulatory Affairs is an exciting area involved across the full value chain. We are responsible for global regulatory strategies to obtain and maintain regulatory licenses for current and future products, responsive to the worldwide business needs of Novo Nordisk. You will work in a fast-paced environment where it is important to be able to manage deadlines in a complex context of international communication across time zones, cultures, and circumstances. The atmosphere in the team is informal and good humour is always welcome.

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